Medical GradeISO 13485FDA Registered30+ Years

Medical Device Components Long-term Partnership

A leading US medical communication equipment manufacturer with products widely used in hospital patient care systems. 30+ years partnership, evolved from cable supplier to full-service design and manufacturing partner.

Client Background

A leading US medical communication equipment manufacturer with products widely used in hospital patient care systems.

Partnership Journey (30+ Years)

Phase 1 (1995-2005): Cable Prototyping and Small-batch Production

Services: Medical-grade cable molding, connector assembly

Building Trust: On-time delivery, consistent quality, flexible cooperation

Phase 2 (2005-2015): Expansion to Plastic Injection Molding

New Services: Housing injection molding, button components, waterproof structures

Certification: Obtained ISO 13485 medical device quality management system certification

Client Support: Completed US FDA Establishment Registration

Phase 3 (2015-Present): Full-service Design and Development Partner

Deep Collaboration: From ID design to structural design verification, full-service support

R&D: Joint development of acoustic structure optimization, waterproof sealing technology (IP65 rating)

Design Services: 3D modeling, mold flow analysis, DFM (Design for Manufacturing) recommendations

Product Showcase

Medical communication device main unit

White PC+ABS housing, PET membrane switches, acoustic hole design

Precision metal contacts

Precision metal contacts ensure stable electrical connection

Medical-grade connector

Medical-grade connector, ISO 13485 compliant

Mold production

Precision mold manufacturing ensures product consistency and high yield

Technical Highlights

Material Selection

  • Housing: PC+ABS alloy with antibacterial surface treatment
  • Buttons: PET membrane switches with customizable nameplate printing
  • Seals: Silicone seals ensuring waterproof performance

Low-volume, High-mix Production

  • Flexible Printing: PET membrane switches allow quick nameplate design changes for different hospital customization needs
  • Low MOQ: Support small-batch production (minimum 100 pieces), suitable for multi-site differentiation
  • Fast Delivery: Standard housing inventory + customized nameplate printing, delivery time reduced to 2-3 weeks

Results

100,000+
Annual Production
99.5%
Yield Rate
100%
Customer Satisfaction
98%+
On-time Delivery

Partnership Highlights

1. Deep Technical Involvement, Not Just a Contractor

Full participation from material selection, structural design to process development. Not just answering 'can we do it', but proactively suggesting 'how to do it better'. Truly becoming a technical partner in product development, not just a supplier.

2. Low-volume, High-mix Production Capability for Hospital Customization

Support small-batch production (minimum 100 pieces) + quick nameplate changes to meet different hospital customization needs. This flexibility that large manufacturers cannot provide becomes our competitive advantage.

3. Regulatory Certification Support, Reducing Client Compliance Risk

Obtained ISO 13485 certification and helped clients complete US FDA Establishment Registration, familiar with medical device regulatory requirements, reducing client compliance risks.

Need a Medical-grade Manufacturing Partner?

We have 30+ years of medical industry experience, ISO 13485 certified, supporting you from design to production